MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY STEERABLE; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	4554
Medical Device Problem Codes	Failure to Capture (1081); Failure to Read Input Signal (1581); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this left ventricular (lv) lead had a history of intermittent loss of capture (loc) and elevated threshold measurements.The patient had premature ventricular contractions (pvcs), however normal pacing was observed shortly afterwards.There did not appear to be fusion.There was a slight wider morphology noted with loc.Technical services (ts) discussed troubleshooting options and programming considerations.The lv was currently programmed from lv ring to rv.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.This product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.
Event or Problem Description
It was reported that this left ventricular (lv) lead had a history of intermittent loss of capture (loc) and elevated threshold measurements.The patient had premature ventricular contractions (pvcs), however normal pacing was observed shortly afterwards.There did not appear to be fusion.There was a slight wider morphology noted with loc.Technical services (ts) discussed troubleshooting options and programming considerations.The lv was currently programmed from lv ring to rv.No adverse patient effects were reported.Additional information received reported that this lv was surgically abandoned and replaced due to high thresholds.It was noted that the cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced during the same procedure due to normal battery depletion (nbd).No additional adverse patient effects were reported.

• Brand Name: ACUITY STEERABLE
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 21118381
• Report Number: 2124215-2025-00542
• Device Sequence Number: 7679578
• Product Code: NVY
• UDI-Device Identifier: 00802526419324
• UDI-Public: 00802526419324
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P050046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/07/2014
• Device Model Number: 4554
• Device Catalogue Number: 4554
• Device Lot Number: 192409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 06/18/2025
• Date Device Manufactured: 09/07/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female